Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 006488
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XYLOCAINE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription AP Yes Yes
XYLOCAINE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription AP Yes Yes
XYLOCAINE LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE;INJECTION Prescription AP Yes Yes
XYLOCAINE LIDOCAINE HYDROCHLORIDE 1.5% INJECTABLE;INJECTION Prescription AP Yes Yes
XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.01MG/ML;2% INJECTABLE;INJECTION Discontinued None No No
XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.01MG/ML;1% INJECTABLE;INJECTION Prescription AP Yes Yes
XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.02MG/ML;2% INJECTABLE;INJECTION Prescription AP Yes Yes
XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.005MG/ML;0.5% INJECTABLE;INJECTION Prescription AP Yes Yes
XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.005MG/ML;1.5% INJECTABLE;INJECTION Prescription AP Yes Yes
XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.005MG/ML;1% INJECTABLE;INJECTION Prescription None Yes Yes
XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.005MG/ML;2% INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/19/1948 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/02/2018 SUPPL-97 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006488s097lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/006488Orig1s097Ltr.pdf
12/22/2017 SUPPL-95 Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/006488s095_s090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/006488Orig1s095, s090ltr.pdf
03/17/2016 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

12/22/2017 SUPPL-90 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/006488s095_s090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/006488Orig1s095, s090ltr.pdf
03/03/2015 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

12/26/2013 SUPPL-88 Manufacturing (CMC)

Label is not available on this site.

07/22/2013 SUPPL-87 Manufacturing (CMC)

Label is not available on this site.

02/20/2013 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

02/13/2013 SUPPL-85 Manufacturing (CMC)

Label is not available on this site.

03/28/2013 SUPPL-84 Labeling-Container/Carton Labels

Label is not available on this site.

02/16/2013 SUPPL-83 Manufacturing (CMC)

Label is not available on this site.

10/29/2013 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

04/09/2013 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

06/11/2013 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

02/19/2010 SUPPL-74 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/006488s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/006488s074ltr.pdf
07/17/2002 SUPPL-66 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/2000 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/2000 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1998 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

05/26/1999 SUPPL-61 Labeling

Label is not available on this site.

05/02/1996 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1996 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

01/03/1996 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

12/08/1997 SUPPL-57 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/18/1995 SUPPL-56 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/11/1995 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

11/21/1994 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

04/13/1993 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/1993 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

10/20/1993 SUPPL-51 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/02/1990 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1989 SUPPL-49 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/02/1988 SUPPL-48 Labeling

Label is not available on this site.

12/02/1988 SUPPL-47 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/11/1987 SUPPL-46 Labeling

Label is not available on this site.

09/11/1987 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1987 SUPPL-44 Labeling

Label is not available on this site.

09/16/1987 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

05/19/1986 SUPPL-42 Labeling

Label is not available on this site.

02/27/1986 SUPPL-41 Labeling

Label is not available on this site.

08/29/1986 SUPPL-40 Labeling

Label is not available on this site.

08/29/1986 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

11/13/1986 SUPPL-38 Labeling

Label is not available on this site.

11/13/1986 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/1991 SUPPL-36 Labeling

Label is not available on this site.

03/21/1991 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/1985 SUPPL-34 Labeling

Label is not available on this site.

03/22/1985 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

12/03/1984 SUPPL-32 Labeling

Label is not available on this site.

06/28/1982 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/25/1982 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1986 SUPPL-29 Labeling

Label is not available on this site.

02/22/1986 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

12/12/1984 SUPPL-27 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/006488Orig1s027.pdf
10/01/1981 SUPPL-26 Labeling

Label is not available on this site.

07/26/1982 SUPPL-25 Labeling

Label is not available on this site.

07/26/1982 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1981 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/1980 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1979 SUPPL-21 Labeling

Label is not available on this site.

12/31/1980 SUPPL-20 Labeling

Label is not available on this site.

02/27/1979 SUPPL-19 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/006488Orig1s019.pdf
04/09/1979 SUPPL-18 Labeling

Label is not available on this site.

04/09/1979 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1979 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/17/1978 SUPPL-15 Labeling

Label is not available on this site.

02/02/1976 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/09/1975 SUPPL-11 Labeling

Label is not available on this site.

07/16/1975 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1975 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1975 SUPPL-8 Labeling

Label is not available on this site.

06/24/1974 SUPPL-6

Label is not available on this site.

05/20/1974 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/1972 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/02/2018 SUPPL-97 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006488s097lbl.pdf
12/22/2017 SUPPL-95 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/006488s095_s090lbl.pdf
12/22/2017 SUPPL-90 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/006488s095_s090lbl.pdf
02/19/2010 SUPPL-74 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/006488s074lbl.pdf

XYLOCAINE

INJECTABLE;INJECTION; 1%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 207182 AUROBINDO PHARMA LTD
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 208474 B BRAUN MEDICAL INC
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 083158 HOSPIRA
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 088329 HOSPIRA
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 083173 INTL MEDICATION
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 208017 SPECTRA MDCL DEVICES
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 088586 FRESENIUS KABI USA
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 088299 HOSPIRA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 203040 AUROBINDO PHARMA LTD
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 203082 AUROBINDO PHARMA LTD
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 080404 FRESENIUS KABI USA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 080408 HOSPIRA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 040302 HOSPIRA
XYLOCAINE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription Yes AP 006488 FRESENIUS KABI USA
XYLOCAINE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription Yes AP 016801 FRESENIUS KABI USA

INJECTABLE;INJECTION; 0.5%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE;INJECTION Prescription No AP 088328 HOSPIRA
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE;INJECTION Prescription No AP 088325 HOSPIRA
XYLOCAINE LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE;INJECTION Prescription Yes AP 006488 FRESENIUS KABI USA

INJECTABLE;INJECTION; 1.5%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1.5% INJECTABLE;INJECTION Prescription No AP 080408 HOSPIRA
XYLOCAINE LIDOCAINE HYDROCHLORIDE 1.5% INJECTABLE;INJECTION Prescription Yes AP 006488 FRESENIUS KABI USA

INJECTABLE;INJECTION; 2%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 207182 AUROBINDO PHARMA LTD
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 040078 HOSPIRA
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 083158 HOSPIRA
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 088294 HOSPIRA
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 083173 INTL MEDICATION
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 088327 HOSPIRA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 203040 AUROBINDO PHARMA LTD
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 203082 AUROBINDO PHARMA LTD
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 017584 FRESENIUS KABI USA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 080404 FRESENIUS KABI USA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 040302 HOSPIRA
XYLOCAINE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription Yes AP 006488 FRESENIUS KABI USA
XYLOCAINE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription Yes AP 016801 FRESENIUS KABI USA

XYLOCAINE W/ EPINEPHRINE

INJECTABLE;INJECTION; 0.01MG/ML;1%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.01MG/ML;1% INJECTABLE;INJECTION Prescription No AP 089644 HOSPIRA
XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.01MG/ML;1% INJECTABLE;INJECTION Prescription Yes AP 006488 FRESENIUS KABI USA

INJECTABLE;INJECTION; 0.02MG/ML;2%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.02MG/ML;2% INJECTABLE;INJECTION Prescription Yes AP 006488 FRESENIUS KABI USA

INJECTABLE;INJECTION; 0.005MG/ML;0.5%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.005MG/ML;0.5% INJECTABLE;INJECTION Prescription No AP 089635 HOSPIRA
XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.005MG/ML;0.5% INJECTABLE;INJECTION Prescription Yes AP 006488 FRESENIUS KABI USA

INJECTABLE;INJECTION; 0.005MG/ML;1.5%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.005MG/ML;1.5% INJECTABLE;INJECTION Prescription No AP 088571 HOSPIRA
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.005MG/ML;1.5% INJECTABLE;INJECTION Prescription No AP 089645 HOSPIRA
XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.005MG/ML;1.5% INJECTABLE;INJECTION Prescription Yes AP 006488 FRESENIUS KABI USA

INJECTABLE;INJECTION; 0.005MG/ML;2%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.005MG/ML;2% INJECTABLE;INJECTION Prescription No AP 089651 HOSPIRA
XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.005MG/ML;2% INJECTABLE;INJECTION Prescription Yes AP 006488 FRESENIUS KABI USA

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